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Process Engineer
Process EngineerKatalyst HealthCares & Life Sciences • Jersey City, NJ
Process Engineer

Process Engineer

Katalyst HealthCares & Life Sciences • Jersey City, NJ
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Job Summary :

  • Lead process design efforts from modeling through to pilot scale and qualification, including technical reviews.
  • Drive process and product characterization to ensure rigorous technical understanding meets scale-up metrics and KPIs (such as scrap, cost and quality)
  • Lead raw material suppliers through raw material iterations, correlating to product design window
  • Drive execution of Learning Plans, seamlessly collaborating with Supply Chain
  • Peer review, coach and develop earlier in career engineers with respect to Process Design

Roles & Responsibilities :

  • Successful experience in scaling up multiple new formulations (from modeling through to production scale) is required. Experience in biomaterials and material development highly preferred
  • Experience in Medical Device industry is preferred; experience in combination products is preferred. Experience with respect to PMA preferred
  • Proven problem-solving skills using analytical technologies is preferred
  • Experience in the following processes (at multiple scales) is required : Powder handling, filling, mixing, transport, isolation, polymer synthesis and reaction (more may be added)
  • Experience Design of Experiments (DOE) is required.
  • Experience in developing protocols and writing completion reports is preferred.
  • Experience in vitro and ex vivo methods for characterizing prototypes and products is preferred
  • Excellent communication, collaboration and influencing skills
  • Demonstrated ability to deliver project outcomes in an ambiguous environment
  • Requires experience managing self-directed work teams
  • Travel up to % may be required (domestic and international)

    • Education & Experience :

  • Bachelor's degree in the following is required Chemical Engineering, Polymer Science, Polymer Engineering
  • Advanced degree is highly preferred.
  • Collaborate with external suppliers, CDMOs and manufacturing facilities to develop processes.
  • Drive selection of lab scale and pilot scale equipment.
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